Events

Alerta De Seguridad para SAFETY SEALS. LOTS NOS.:5031 À 5341.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC MIDAS REX DIV MEDTRONIC INC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    56
  • Fecha
    2001-04-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    This safety seal may be inched during self-cleaning, which may cause seal shifting to incorrect motor connection mounting positions. the incorrect position may result in greater probabilities of oil leakage and deintegration of the seal during surgery. the manufacturer began a removal for a letter sent january 18, 2001.
  • Acción
    VERIFY THAT YOU RECEIVED THE LETTER SENT JANUARY 18, 2001 FROM MEDTRONIC MIDAS REX. IDENTIFY AND ISOLE ALL PRODUCTS AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR MEDTRONIC REPRESENTATIVE OR MIDAS REX BY PHONE 0021-1-817-788-6400.

Device

SAFETY SEALS. LOTS NOS.:5031 À 5341.

Manufacturer

MEDTRONIC MIDAS REX DIV MEDTRONIC INC
  • Source
    ANVSANVISA